A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Different Doses of Amino Acids in 5AA+CrPic Water on Glucose Homeostasis in a Healthy Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Blood glucose response
研究概览
简要总结
It has previously been shown that a carbonated water including a defined amount of amino acids and chromium can decrease the postprandial glucose response. In this study, the effect of three different doses of amino acids on glucose excursions after a standardized test meal will be evaluated in healthy subjects. The study will be conducted in a randomized, single center, crossover, double-blinded, placebo controlled design including 25 participants. The primary endpoint of the study is the incremental area under the curve for capillary blood glucose (iAUC) within 180 minutes after ingestion of the meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18-25 (±0.5) kg/m²
- •Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
- •Healthy as determined by medical history and information provided by the volunteer
- •Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits
- •Has given voluntary, written, informed consent to participate in the study
排除标准
- •Pregnancy or lactation
- •Known Type I or Type II diabetes
- •Undetected Type I or Type II diabetes (fasting blood glucose < 6.1 mmol/L at first test day)
- •Use of antibiotics
- •Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
- •Allergy to test product or placebo ingredients
- •Participants restricted to a vegetarian or vegan diet
- •Intolerance to lactose or gluten
- •Acute infection
- •Individuals who are averse to venous catheterization or capillary blood sampling
- •Alcohol or drug abuse
- •Currently active smokers (tobacco products, and e-cigarettes)
- •Participation in other clinical research trials
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Any other condition which in the PI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual
- •Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the PI
- •Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the PI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless recommended by their physician.
研究组 & 干预措施
Placebo drink
A standardized breakfast meal will be provided together with carbonated water containing aroma
干预措施: Placebo drink (Other)
5AA+CrPic Water Dose 1
A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA and CrPic
干预措施: 5AA+CrPic Water (Dietary Supplement)
5AA+CrPic Water Dose 2
A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/2 of Dose 1) and CrPic
干预措施: 5AA+CrPic Water (Dietary Supplement)
5AA+CrPic Water Dose 3
A standardized breakfast meal will be provided together with carbonated water containing aroma and active components 5AA (1/4 of Dose 1) and CrPic
干预措施: 5AA+CrPic Water (Dietary Supplement)
结局指标
主要结局
Blood glucose response
时间窗: 3h postprandial phase
The difference in three-hour incremental area under the curve (AUC) for capillary blood glucose between 5AA+CrPic test products and placebo following a standardized breakfast meal.
次要结局
- Cmax of capillary blood glucose(3h postprandial phase)
- Serum insulin response(3h postprandial phase)
- Venous blood glucose response(3h postprandial phase)
- GLP-1 response(1h postprandial phase)
- Capillary blood glucose response(2h postprandial phase)